Regulatory Science Lead

il y a 3 semaines

Anderlecht, Belgique UCB S.A. Temps plein

**Make your mark for patients.**

We’re here because we want to build the future and transform patients’ lives for the better. To achieve that, we need the brightest minds and biggest hearts. That’s why our Talent Acquisition Team looks for passionate people inside and outside the company. Are you interested in an internal move that will allow you to explore how much more you can do to make a difference for people living with severe disease?

We are looking for a **Regulatory Science Lead** to join us in our **Regulatory **function, based in either our Brussels (Belgium) or Slough (UK) offices

The Regulatory Science Lead is responsible for all regulatory activities related to product development and marketing authorizations in the (region) region and is the primary contact point within UCB for any regulatory issues with the product and with designated health authorities.

**What you’ll do**
- Develops and implements the regional regulatory strategy and plan consistent with the business objectives, inputting regional expertise into the global regulatory strategy and global planning in line with the GRL.
- Serve as the primary regional point of contact for the GRL, affiliates, and other Practices/Functions
- If applicable, responsible for facilitating and coordinating the regulatory regional product team in collaboration with GRL to ensure that objective priorities are met.
- Primary contact point with the (region) health authorities building strong relationships
- Responsible for ensuring that the regional regulatory strategy for the specific product(s), have been negotiated (if appropriate) with the regional health authorities and that the regulatory risks have been identified and mitigated
- Responsible for ensuring that the regional regulatory strategies, risks and mitigations and overall plans are effectively discussed with, endorsed by and communicated to the GRL, GRA TA Head, GRA LT, and other functions and affiliates as needed

I**nterested? For this position you’ll need the following education, experience and skills**:

- Bachelor’s degree, Master’s preferred
- Several years hands-on experience in Regulatory Affairs, with knowledge of assigned regional regulatory procedures and legislation for complex therapeutics.
- Preferably experience within Life Cycle management & development projects.
- Communication skills - knows when and how to communicate, using strong interpersonal skills and written communications when appropriate.
- Build effective partnerships - identifies opportunities and takes actions to build effective relationships within team and with other areas.

**Why you should apply**

At UCB, we welcome passionate individuals who thrive on change and are ready make their mark for patients. Working for us, you will discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact while putting continuous efforts into cultivating a workplace culture where everyone feels included, respected and has equitable opportunities. Through meaningful recognition and a motivating atmosphere, we aim to provide an optimal experience by caring about and valuing our employees - just as we do for the patients we serve.

RANDATUCB

**About us.**

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

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